Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE)

Informazioni relative al progetto

SCIENCE

ID dell’accordo di sovvenzione: 643478

DOI 10.3030/643478

Progetto chiuso

Data della firma CE 3 Dicembre 2014

Data di avvio 1 Gennaio 2015

Data di completamento 31 Dicembre 2020

Finanziato da

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Costo totale € 5 998 882,00

Contributo UE € 5 998 882,00

Coordinato da

REGION HOVEDSTADEN
Denmark

Risultati finali

Other (4)

First patient treated

First patient treated.

IMP production final

Production of IMP for clinical trial final.

Clinical trial kick-off

Clinical Trial Kick-off meeting with all clinical partners.

International workshop

Arrangements for an international scientific workshop on stem cell-based treatment of cardiac disease.

Documents, reports (13)

Monitoring of clinical sites

Monitoring of clinical sites.

Status on posting of results

Report on the status of the posting of results (to the study registry).

Training logs

Training logs for personnel complete

Quantification of cardiac fibrosis

A clinically applicable technique to determine and quantify cardiac fibrosis by MRI

Determination of local deformation parameters

Easy to use protocol for 3D echocardiography to determine local deformation parameters. Use the local myocardial deformation to assess the local effects of cardiac regenerative therapy on local cardiac function

Comprehensive cost-PU effectiveness

Comprehensive cost-PU effectiveness: Using country comparisons results and refinement of methods, a conclusive assessment of the economic effects of ASC therapy can be given.

Planning tool for cardiac cell therapy

Validation of a novel treatment planning tool for cardiac cell therapy, that is based on real time image integration

IP management

IP management final.

Dissemination

Dissemination to relevant groups and meetings. Production technology published in peer reviewed journal. Clinical trial design published in peer reviewed journal.

Preliminary cost-effectiveness analysis

First preliminary results of health economics: Standard cost-effectiveness analysis of ASC therapy for each country involved, analysis of country differences

All approvals package

All approvals from national ethics committees and national competent authorities of all study sites recieved.

Method for a financial analysis

Developed tools: A methodology for a financial analysis of innovative medical technology will be set up comprising a software tool to be used on the spot by the developers of the technologies

Qualification of production facility

Documentation of proper classification for sterile GMP production.

Demonstrators, pilots, prototypes (2)

Production initiated

Production ready to start.

Clinical databases

IWRS, eCRF and database developed

Websites, patent fillings, videos etc. (1)

Website

Establishment of SCIENCE website for public and partner use.

Pubblicazioni

Peer reviewed articles (4)

Intracoronary autologous bone marrow cell transfer after acute myocardial infarction: abort and refocus

Autori: Jozef Bartunek, Wojtek Wojakowski
Pubblicato in: European Heart Journal, Numero 38/39, 2017, Pagina/e 2944-2947, ISSN 0195-668X
Editore: Oxford University Press
DOI: 10.1093/eurheartj/ehx300

Global position paper on cardiovascular regenerative medicine

Autori: Francisco Fernández-Avilés, Ricardo Sanz-Ruiz, Andreu M. Climent, Lina Badimon, Roberto Bolli, Dominique Charron, Valentin Fuster, Stefan Janssens, Jens Kastrup, Hyo-Soo Kim, Thomas F. Lüscher, John F. Martin, Philippe Menasché, Robert D. Simari, Gregg W. Stone, Andre Terzic, James T. Willerson, Joseph C. Wu, Francisco Fernández-Avilés, Andre Terzic, Lina Badimon, Kathleen Broughton, Darcy L
Pubblicato in: European Heart Journal, Numero 38/33, 2017, Pagina/e 2532-2546, ISSN 0195-668X
Editore: Oxford University Press
DOI: 10.1093/eurheartj/ehx248

Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE)

Autori: Christina Paitazoglou, Martin W. Bergmann, Bojan Vrtovec, Steven A.J. Chamuleau, Bas van Klarenbosch, Wojtek Wojakowski, Aleksandra Michalewska-Włudarczyk, Mariann Gyöngyösi, Annette Ekblond, Mandana Haack-Sørensen, Kai Jaquet, Karsten Vrangbaek, Jens Kastrup
Pubblicato in: European Journal of Heart Failure, 2019, ISSN 1388-9842
Editore: Elsevier BV
DOI: 10.1002/ejhf.1412

Global Overview of the Transnational Alliance for Regenerative Therapies in Cardiovascular Syndromes (TACTICS) Recommendations

Autori: Francisco Fernández-Avilés, Ricardo Sanz-Ruiz, Andreu M. Climent, Lina Badimon, Roberto Bolli, Dominique Charron, Valentin Fuster, Stefan Janssens, Jens Kastrup, Hyo-Soo Kim, Thomas F. Lüscher, John F. Martin, Philippe Menasché, Fausto J. Pinto, Robert D. Simari, Gregg W. Stone, Andre Terzic, James T. Willerson, Joseph C. Wu
Pubblicato in: Circulation Research, Numero 122/2, 2018, Pagina/e 199-201, ISSN 0009-7330
Editore: Lippincott Williams & Wilkins Ltd.
DOI: 10.1161/circresaha.117.312099

Diritti di proprietà intellettuale

Patent (1)

STEM CELL THERAPY BASED ON ADIPOSE-DERIVED STEM CELLS

Numero candidatura/pubblicazione: 20 16075407
Data: 2016-10-21